Drug Evaluation Committee Innovative Changes in Data Management SCDM Reflection papers "The Evolution of Clinical Data Management to Clinical Data Science"
Data Science Subcommittee
November 2020
Clinical trials are undergoing a transformation in study design and evolving technologies that can/should be utilized. In addition, regulatory aspects and the quality required in clinical trials are becoming more diverse in terms of what needs to be considered and what needs to be resolved.
In light of the above, the Society for Clinical Data Management (SCDM) is releasing the first edition in June 2019 (first edition) and the second edition in March 2020 (Part 2) as information necessary to organize and understand the skill sets required, roles to be fulfilled, and future vision to be pursued as a data manager in clinical trials. Reflection papers "The Evolution of Clinical Data Management to Clinical Data Science" released by the Society for Clinical Data Management (SCDM) in June 2019 (first edition) and March 2020 (Part 2).
Please note that this publication is a slide-based deliverable dedicated solely to the introduction of the SCDM reflection papers, with the aim of releasing them as soon as possible in the context of the pending data management transformation in the wake of COVID-19. The views of the Pharmaceutical Manufacturers Association of Japan (PMAJ) are not included in this document, and specific issues and measures will continue to be discussed.
SCDM_part2_introductory material（5.8MB)
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